“Perhaps CYDY received the recommendation, and i
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Posted On: 10/19/2020 11:18:10 AM
“Perhaps CYDY received the recommendation, and is discussing with the FDA today, and scheduled the call for tomorrow.”
I believe this is a reasonable option, as Dr. STJ’s comment from October 7th and NP’s comments on Fox News indicate that the FDA has seen the S/C data or at least they’ve seen DSMC’s recommendation (which would indicate they’d need to review the data in order to agree of disagree with the DSMC’s recommendation).
But where it gets confusing is this: Dr. STJ’s comment indicates the FDA has been reviewing the data since early October. NP’s comments on Fox News indicate CYDY was expecting the DSMC’s recommendation at the end of last week. The DSMC wouldn’t directly go to the FDA, they’d first go to the company. So something isn’t lining up with a few of the potential scenarios. Is it possible that Dr. STJ meant the FDA was reviewing the M2M data and not the S/C interim data? Or maybe he misspoke? If so, that would mean CYDY got the DSMC’s recommendation this past week and possibly is discussing their recommendations with the FDA prior to tomorrow’s CC.
I still believe NP would’ve immediately PRed a recommendation to halt the trial (even if the FDA ultimately doesn’t agree with the recommendation), but the 5 day period between the PR for the CC and the actual CC leaves the door open for many scenarios.
I believe this is a reasonable option, as Dr. STJ’s comment from October 7th and NP’s comments on Fox News indicate that the FDA has seen the S/C data or at least they’ve seen DSMC’s recommendation (which would indicate they’d need to review the data in order to agree of disagree with the DSMC’s recommendation).
But where it gets confusing is this: Dr. STJ’s comment indicates the FDA has been reviewing the data since early October. NP’s comments on Fox News indicate CYDY was expecting the DSMC’s recommendation at the end of last week. The DSMC wouldn’t directly go to the FDA, they’d first go to the company. So something isn’t lining up with a few of the potential scenarios. Is it possible that Dr. STJ meant the FDA was reviewing the M2M data and not the S/C interim data? Or maybe he misspoke? If so, that would mean CYDY got the DSMC’s recommendation this past week and possibly is discussing their recommendations with the FDA prior to tomorrow’s CC.
I still believe NP would’ve immediately PRed a recommendation to halt the trial (even if the FDA ultimately doesn’t agree with the recommendation), but the 5 day period between the PR for the CC and the actual CC leaves the door open for many scenarios.
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